An interventional study of Aveir DR Leadless Pacemaker System in Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder and Bradycardia, sponsored by Abbott Medical Devices. Completed at 78 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
Among 28 studies in Bradycardia by Abbott Medical Devices — 5 open to participants now, 8 under way, none of them phase 3. Bradycardia · Abbott Medical Devices.
Among the 28 studies in Bradycardia by Abbott Medical Devices, this one is the 4th largest by enrollment of the 11 interventional ones, is one of 4 that started in 2022, is one of 10 with no phase, and was the 17th registered.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's enrollment of 464 is above the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →5 of the 28 studies in Bradycardia by Abbott Medical Devices are open now, in 11 countries. Each count lists the studies.
Of the 51 Bradycardia studies recruiting now, 34 (67%) set no upper age limit and 9 (18%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2022.
Median enrollment 249 across the 11 interventional studies, 586 across the 17 observational. Of the 20 that completed or were terminated, 12 (60%) have results posted.
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
3 of the studies in Bradycardia by Abbott Medical Devices that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07877805Abbott Medical DevicesMerlin Expanded ECG NSR | 2027-01 |
| NCT07217392Abbott Medical DevicesLeft Bundle Branch Area Pacing (LBBAP) PMCF Study | 2027-04-30 |
| NCT07287423Abbott Medical DevicesLEAP 2 Chronic EFS | 2027-07 |
Among the 28 studies in Bradycardia by Abbott Medical Devices, from their registry updates:
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker.
Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's enrollment of 464 is above the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Compared within Bradycardia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arrhythmias, Cardiac. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non randomized arm
Device: Aveir DR Leadless Pacemaker System
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Percentage of Participants Free From Aveir DR System-Related Complications at 3-months
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
Time frame: 3 months
Percentage of Participants Free From Aveir DR System-Related Complications at 12-months
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
Time frame: 12 months
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.
Time frame: 3 months
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.
Time frame: 12 months
Percentage of Participants With AV Synchrony Success Rate at Rest While Seated
AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.
Time frame: 3 months
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months
The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.
Time frame: 3 months
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months
The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.
Time frame: 12 months
Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing
Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.
Time frame: 3 months
Subject enrollment in the Aveir DR i2i IDE study began on February 2, 2022 in Czech Republic, February 24, 2022 in the US, April 7, 2022 in Canada, October 14, 2022 in Hong Kong, and February 9, 2023 in Taiwan. The study enrolled 464 de novo subjects at 77 sites worldwide
| Milestone | Enrolled de Novo Cohort |
|---|---|
| Started | 464 |
| Attempted implant | 452 |
| Predischarge visit | 450 |
| 1-month visit | 443 |
| 3-month visit | 442 |
| 6-month visit | 435 |
| 12-month visit | 360 |
| 18-month visit | 100 |
| Completed | 30 |
| Not completed | 434 |
| Withdrew: No attempted implant, subjects withdrawn | 12 |
| Withdrew: Death | 16 |
| Withdrew: System explant | 5 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawn by investigator | 1 |
| Withdrew: Visit not due | 306 |
| Withdrew: Visit within window but not completed | 92 |
| Withdrew: Unsuccessful implant | 1 |
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
| percentage of participants | Primary Analysis Population |
|---|---|
| Percentage of Participants Free From Aveir DR System-Related Complications at 3-months | 90.3 (87 to 93.7) |
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
| percentage of participants | Primary Analysis Population |
|---|---|
| Percentage of Participants Free From Aveir DR System-Related Complications at 12-months | 88.6 (84.5 to 91.8) |
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.
| percentage of participants | Primary Analysis Population |
|---|---|
| Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months | 90.8 (87.5 to 94.1) |
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.
| percentage of participants | Primary Analysis Population |
|---|---|
| Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months | 92.8 (89.7 to 95.8) |
AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.
| percentage of participants | Primary Analysis Population |
|---|---|
| Percentage of Participants With AV Synchrony Success Rate at Rest While Seated | 98.2 (96.6 to 99.8) |
The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.
| percentage of participants | Primary Analysis Population |
|---|---|
| Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months | 91.3 (88.1 to 94.5) |
The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.
| percentage of participants | Primary Analysis Population |
|---|---|
| Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months | 91.0 (87.1 to 93.7) |
Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.
| unitless | Chronotropic Assessment Exercise Protocol (CAEP) Group |
|---|---|
| Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing | 0.91 (0.78 to 1.04) |
Collected over From implant attempt to last subject follow-up, ranging from 0 to 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled de Novo Cohort With Attempted Implant | 16/452 (3.5%) | 202/452 (44.7%) | 366/452 (81%) |
| Event | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Cardiac Arrhythmia - Atrial FibrillationCardiac disorders | 41/452 |
| Heart FailureCardiac disorders | 18/452 |
| Device DislogdementInjury, poisoning and procedural complications | 12/452 |
| Cardiac Arrhythmia - Supraventricular ArrhythmiaCardiac disorders | 11/452 |
| Infection, Local at Access Site, or SystemicInfections and infestations | 10/452 |
| PalpitationsCardiac disorders | 9/452 |
| PainMusculoskeletal and connective tissue disorders | 7/452 |
| Threshold ElevationGeneral disorders | 7/452 |
| Accidental Injury/Mechanical TraumaInjury, poisoning and procedural complications | 6/452 |
| Respiratory Failure/Respiratory InsufficiencyRespiratory, thoracic and mediastinal disorders | 6/452 |
| Event | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Cardiac Arrhythmia - Atrial FibrillationCardiac disorders | 37/452 |
| PainMusculoskeletal and connective tissue disorders | 34/452 |
| PalpitationsCardiac disorders | 34/452 |
| DizzinessGeneral disorders | 29/452 |
| Covid-19 InfectionsInfections and infestations | 27/452 |
| DyspneaGeneral disorders | 25/452 |
| Access Site Bleeding EventInjury, poisoning and procedural complications | 23/452 |
| Threshold ElevationGeneral disorders | 22/452 |
| Infection, Local at Access Site, or SystemicInfections and infestations | 21/452 |
| Chest Pain - Non-CardiacGeneral disorders | 17/452 |
| Age, Continuous(years) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Mean | 69.8 ± 13.3 |
| Sex: Female, Male(Participants) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Female | 174 |
| Male | 278 |
| Race/Ethnicity, Customized(participants) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 46 |
| Black or African American | 13 |
| White | 282 |
| Declined/Unable to Disclose | 104 |
| Unknown | 5 |
| Multi-Racial | 1 |
| Race/Ethnicity, Customized(Participants) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Hispanic or Latino | 15 |
| Not Hispanic or Latino | 331 |
| Declined/Unable to Disclose | 100 |
| Unknown | 6 |
| Region of Enrollment(Participants) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Hong Kong | 11 |
| United States | 280 |
| Czechia | 33 |
| Japan | 24 |
| United Kingdom | 8 |
| Spain | 18 |
| Canada | 33 |
| Austria | 5 |
| Netherlands | 4 |
| Belgium | 6 |
| Taiwan | 5 |
| Italy | 7 |
| France | 18 |
| Height(cm) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Mean | 170.7 ± 10.8 |
| Weight(kg) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Mean | 81.6 ± 19.8 |
| BMI(kg/m^2) | Enrolled de Novo Cohort With Attempted Implant |
|---|---|
| Mean | 27.8 ± 5.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Aveir DR i2i Study Steering Committee.
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD will be available following publication of primary results for 25 years following study completion date.
Access criteria: Proposals for requesting individual data may be submitted to the Sponsor at AveirDR_IDE@abbott.com.
Ran from Feb 2022 to primary completion in Aug 2023, 18 months.
Results were first posted in Nov 2024, 1 year 3 months after primary completion.
Of 36 industry-sponsored interventional studies with no phase under Bradycardia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's 18 months is close to that.
Counting every sponsor, half of 83 studies reached it within 21 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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